SUPPLY CHAIN ARTICLES
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The RNA Therapeutics Supply Chain: A Platform of Relationships
Conversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.
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The Expanding Patent Landscape For RNA-Based Therapeutics
The COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.
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ARW's ATMP Manufacturing Must-Reads (2024 NEW YEAR'S RESOLUTIONS EDITION!)
Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.
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The Price Is… Almost Right: mRNA Edition! COGS Reduction Strategies
The following article will outline the current state of COGS in the mRNA industry and the work he and his colleagues undertook to more effectively utilize raw materials. But heaven forbid this be your normal conference panel write-up. No, below I share Parrella’s insights, but in the form of a never-before released episode of The Price is Right…or perhaps more fittingly given the state of the industry today, this spectacle is more aptly titled: The Price is…Sort Of, Almost, Not Quite Right!
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Defining The RNA Therapeutics Industry In 2023
Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.
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“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles
In the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Learn how to approach CRISPR cell and gene therapy development challenges, such as regulatory hurdles, ensuring consistency, finding qualified and experienced staff, and obtaining GMP-Grade reagents.
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Read through the results of our efforts to produce an optimal protocol for the transient transfection of hMSCs with pDNA or mRNA using non-viral means.
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Uncover how how switching from LAL to rFC can enhance sustainability, improve testing reliability, and strengthen supply-chain resilience in endotoxin testing.
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Explore a program focused on achieving process consistency through risk mitigation in four key areas: raw materials sourcing, equipment, manufacturing processes, and finished product testing.
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Researchers demonstrate a delivery mechanism that is a simple and ready-to-use transfection reagent that leads to outstanding transfection efficiencies in known hard-to-transfect stem cells.
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From harsh chemicals to gentle enzymes: Explore the groundbreaking shift in nucleotide synthesis, making drug manufacturing cleaner, greener, and more efficient.
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GMP-Source is a more robust, less rigid alternative to full cGMP production that mirrors nearly all of the oversight and quality standards of full cGMP production while relaxing certain commercial standards, helping companies overcome the hurdles that can stall early development.